Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 11401–11420 of 38,428 recalls
Recalled Item: QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075)
The Issue: The firm identified sixteen (16) faulty cartridges in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific ROTAPRO
The Issue: Manufacturing instructions did not include the directions to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Identification Cards associated with Sprint Quattro Lead
The Issue: The back of some Medical Device Identification Cards
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Identification Cards associated with Astra XT DR Implantable
The Issue: The back of some Medical Device Identification Cards
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigniCap Delta Scalp Cooling System
The Issue: Instructions for Use (IFUs) updated to include use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vscan Extend
The Issue: The firm identified that the Vscan Extend device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vscan Extend
The Issue: The firm identified that the Vscan Extend device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vscan Extend
The Issue: The firm identified that the Vscan Extend device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vscan Extend
The Issue: The firm identified that the Vscan Extend device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vscan Extend
The Issue: The firm identified that the Vscan Extend device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vscan Extend
The Issue: The firm identified that the Vscan Extend device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vscan Extend
The Issue: The firm identified that the Vscan Extend device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing)
The Issue: Devices are determined to be inconsistent with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard Clinical Packaging Solutions Item Number 830096005
The Issue: The kit contains a non-sterile needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger
The Issue: The wireless rechargers (WR; WR9200 and WR9220; included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.